Clinical Trial: Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT

Brief Summary:

Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use in vital teeth has demonstrated significant color change post-treatment leaving it ineffective for esthetic use..

The new formulation will be tested to see if has the same effect.


Detailed Summary: This randomized control, split-mouth trial will use 50 pediatric subjects selected from the patient population in the pediatric dental clinics at Baylor College of Dentistry and in select faculty private practices. The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with an MTA pulpotomy and restored with a SSC; thus, approximately 50 teeth will be treated for each treatment group. The restoration type will be randomized as to which side will receive the SSC or composite using sealed, opaque envelopes. Approximately 50 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis from a similar study.
Sponsor: Texas A & M University Baylor College Of Dentistry

Current Primary Outcome:

  • Color stability [ Time Frame: 2 years ]
    Dental intraoral photographs will evaluated
  • Internal resorption [ Time Frame: 2 years ]
    Dental radiographs will be evaluatedresorption
  • external resorption [ Time Frame: 2 years ]
    Dental radiographs will be evaluated resorption
  • Bone loss [ Time Frame: 2 years ]
    Dental radiographs will be evaluated for intraradicular or periapical bone loss
  • Widening of periodontal ligament space [ Time Frame: 2 years ]
    Dental radiographs will be evaluated for widening of the PDL space


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Texas A & M University Baylor College Of Dentistry

Dates:
Date Received: March 3, 2016
Date Started: November 2014
Date Completion: December 2017
Last Updated: March 7, 2016
Last Verified: March 2016